Nov. 15, 2004 -- Product information for Mifeprex, also known as the "abortion pill" RU-486, is being revised to warn of rare but serious side effects, the FDA said today.
The so-called "black box labeling" is being changed to warn of the rare risk of serious bacterial infections, sepsis (a life-threatening form of infection that can lead to uncontrolled inflammation in the body), bleeding, and death that may occur following any abortion, including that with Mifeprex.
The FDA and the drug's manufacturer, Danco Laboratories, received reports of serious bacterial infection, bleeding, ectopic (tubal) pregnancies that ruptured, and a sepsis death, which led to the labeling revision, according to an FDA statement.
The new label says these conditions can occur without the usual signs of infection, such as fever and tenderness during examination. It warns that prolonged, heavy bleeding can require surgery to stop it. And it says health care providers should screen patients for possible ectopic pregnancy because its symptoms are similar to symptoms of a medical termination of pregnancy (cramping, nausea, diarrhea, vaginal bleeding). Mifeprex should not be used for ectopic pregnancies.
Mifeprex is a nonsurgical abortion option for the first seven weeks of pregnancy. It is used with a second drug, misoprostol, to complete the procedure.